The Saatchi Bill: A Quacks’ Charter

The Saatchi Bill is based on a false premise, shows no understanding of medical research and removes vital protections for patients.

Maurice Saatchi, the former advertising businessman and Tory peer, has introduced a Bill to parliament designed to encourage medical innovation. After the death of his wife from cancer, Saatchi believed that doctors were being held back from making innovations that could save lives.

The “Medical Innovation” Bill is designed to encourage and protect doctors who wish to try new things in cancer treatment with the aim of speeding up the rate of discovery. Saatchi says that current treatments are “medieval, degrading and ineffective” and that doctors are prevented from deviating from standard care for fear of medical negligence claims. Fear of litigation is a “barrier to progress”.

However, at present the Bill is deeply flawed, will remove vital protections from patients and, in my opinion, be a quacks’ charter which will allow mavericks, charlatans and the deluded to mislead and harm people at a most desperate time. On her blog, Margaret McCartney points out many problems with the Bill as it exists. She points out that it is not true that a doctor will be found negligent if they depart from the existing range of medical guidelines for a condition.

Indeed, Nigel Poole QC states that the doctor will only be negligent if such a course of action could not be supported by a responsible body of medical opinion,

Current clinical negligence law provides redress to patients who have suffered harm as a result of treatment which would not be supported by any responsible body of medical opinion. This Bill seeks to remove that right of redress where a doctor has taken a decision to treat in what the Bill defines as a “responsible” manner, even when no other doctor would support the treatment actually given. We do not believe that depriving patients of the right of redress is the best way to promote medical innovation.

This provides a check against mavericks and quacks. They would first have to be sure they would have the support of an appropriate and responsible medical body. Thus, doctors can innovate if they have good ideas, but in order to protect the patient, the innovative ideas must be supported by a wider body. Removing this protection, opens up the possibility of patients being subjected to implausible and evidence free interventions – quackery.

Margaret McCartney says that removing this protection would, “support any number of evidence –free interventions in any number of alternative or complementary medicine sectors, as well as those clinics and hospitals promising life saving treatments and breakthroughs despite the absolute lack of trial evidence for their interventions. I am very clearly not a lawyer, but to pretend that this gives patients any protection from naked quackery would be misguided.“. Bizarrely, the Bill says that it would be forbidden to “carry out treatment for the purposes of research”.

I categorically state that in over 40 years first hand experience at the “coal face” on innovative research governed according to the highest ethical principles, I have never once experienced any obstacle that could even indirectly be linked to fear of litigation.
Professor Michael Baum

Listening to Saatchi and reading the text of the Bill, it would appear that he believes that a breakthrough in cancer will come about through the idea of ‘one man or woman’. All that then is required is for a doctor to be allowed to try out this idea on a patient free from proper consideration and constraint that ethics and science demand. This is not how cancer breakthroughs will happen.

But this alluring narative will play into the hands of those that do wish to exploit desperare people looking for cures. We need look no further than the example given by Dr Burzynski of Texas who has been playing the lone hero curing cancer for several decades without publishing any significant results and whilst making extravagant claims. The media love this type of ‘medical hero’ who fights against the “protective medical establishment” and the “greedy pharmaceutical companies” to save the lives of children and of those medicine has ‘given up on’.

Last autumn, the Daily Mail showed how Burzynski had cured young mother Laura Hymas of a brain tumour when the NHS had given up. The Daily Mail have not been so quick to point out that this was not true and that she tragically died a week ago.

In the UK, we have a small but significant group of registered doctors who are prepared to treat cancer patients with so-called alternative medicine. Some private doctors are prepared to offer evidence-lacking treatments like high dose vitamin C, oxygen therapy or diets and vitamins. There are a dwindling number of doctors who treat using nonsense like homeopathy. At the moment, they are quite constrained by the law and their regulators. I fear that Saatchi’s Bill could let many of them off the leash.

A conference is being held in Exeter this June where cancer patients will be presented with many of these disproven, nonsensical and irrational treatments. David Colquhoun examined the claims of many of the participants in last year’s conference. These are ideas that lure the desperate in, exploit them at their most vulnerable and provide no health benefits. We do not want more of this.

Perhaps the biggest clue about the effects of this bill is to see who is most supporting it. The Alliance of Natural Health, an industry lobby organisation for the ‘natural health sector [vitamin pill pedlers], has called on its supporters to respond to the public consultation. The ANH regularly undermines evidence in medicine and sees the Bill as a way of introducing so-called integrative treatments without having to provide robust RCT evidence,

Saatchi’s bill importantly also indirectly fingers the so-called ‘gold standard’ of evidence-based medicine, the randomised controlled trial (RCT). The RCT has been the backbone of medical decision-making for over 30 years. Yet it provides a huge barrier to innovation. It is also particularly inappropriate for complex, multi-pronged interventions that might involve dietary and lifestyle interventions, the very processes that are increasingly implicated in mediating key chronic diseases like cancer, heart disease, type 2 diabetes and obesity. RCTs are hugely expensive and time-consuming, and provide a limited perspective on what actually can happen within a clinical setting. Those with misgivings about the value of the RCT in medicine will probably want to support Saatchi’s bill. It proposes that, if methods other than an RCT provide plausible evidence for the likely effectiveness of a given treatment in a specific situation, the treatment in question should be allowed with no risk of a claim being made against the practitioners involved. The proposed treatment must also be supported by the medics and patients involved.

RCTs are the only way we know of proving that treatments actually work. That is why supporters of quackery try desperately to discredit RCT evidence and undermine the understanding of medical evidence amongst the public.

If you are concerned about this, it is not too late to add your voice – although you must do by tomorrow – 24th April. If you have time, the full consultation document is here. Otherwise, simply add your name to this blog where names will be collated and sent in.

Professor Susan Bewley in the BMJ. “It is both an insult, and dangerous, for one rich persuasive individual with deep pockets, access and influence to tell the medical profession that it has not been innovative (enough) and that we need a Bill to help us do what we already do safely and legally.”

Margaret McCartney in the BMJ: The Saatchi Bill is an ‘open door to quackery, misguided and should be withdrawn’.

The key test of this must be to ask Saatchi to name any treatment that has not been offered because of fear of medical negligence claims, but which is known to be ethically and scientifically supportable. I would bet you ten of the BRITONS’ pounds that he cannot name one – or rather, that the ones he will name are well known to skeptics (laetrile, Gerson therapy and the like).

I would also bet you that Chris Woiolams supports this bill, which would be proof in my book that it’s a bad idea!

A remarkable draft bill — we really have parliamentarians naive enough to propose entirely removing checks and balances for patient safety in the unproven name of “innovation”? There is not even any requirement that these “responsible” practitioners pay heed to strong *negative* evidence for their treatment as long as they say they were being innovative: it’s clear why the quacks are so enthusiastic. Either it’s well-intentioned but incompetent, or it’s another fully intentional way to provide a legal loophole for quackery: neither is a recommendation.

By the way, the link to the consultation web page is wrong in the consultation doc itself: should be http://medicalinnovationbill.dh.gov.uk i.e. without any www. The questions are rather leading, e.g. “Do you have experience or evidence to suggest that the possibility of litigation sometimes deters doctors from innovation?” seems designed to encourage positive answers while not obviously allowing “I have evidence that it doesn’t” or “It sometimes happens, but not significantly so” responses. The main question that is answerable by non medical professionals (despite also being phrased leadingly) is at http://medicalinnovationbill.dh.gov.uk/2014/02/13/question-9-overall-do-you-agree-the-draft-bill-should-become-law/ Since this article (and Margaret & Nigel’s) there seems to be a trend for “no” responses… just in time.

I find it amazing that Govt departments are allowed to get away with such sloppy and biased “consultations”, but then I’m also naive enough to be astounded that a national newspaper would allow a paid media advocate to write a positive article about their “client” without declaring their interest… apparently I will never learn.